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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05852938




Registration number
NCT05852938
Ethics application status
Date submitted
2/05/2023
Date registered
10/05/2023
Date last updated
20/05/2024

Titles & IDs
Public title
A Study of BION-1301 in Adults With IgA Nephropathy
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Secondary ID [1] 0 0
CHK02-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Immunoglobulin A Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BION-1301
Treatment: Drugs - Placebo

Experimental: BION-1301 - 600mg subcutaneous administration every 2 weeks for 104 weeks

Placebo Comparator: Placebo - subcutaneous administration every 2 weeks for 104 weeks


Treatment: Drugs: BION-1301
BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.

Treatment: Drugs: Placebo
Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in proteinuria
Timepoint [1] 0 0
40 weeks or approximately 9 months
Secondary outcome [1] 0 0
Change in eGFR
Timepoint [1] 0 0
104 weeks or approximately 2 years

Eligibility
Key inclusion criteria
- Male and female subjects aged = 18 years at the time of signing the informed consent
form (ICF) prior to initiation of any study specific activities/procedures.

- Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the
opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of
the report must be available for review by the Sponsor or designee prior to
randomization. If biopsy report within 10 years is not available, re-biopsy may be
permitted upon discussion with the Medical Monitor.

- eGFR = 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.

- Total urine protein = 1.0 g/day and UPCR = 0.7 g/g (700 mg/g), as measured from an
adequate 24-hour urine collection at Screening by a central laboratory.

- Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to
Screening unless intolerant to ACEi/ARB. May also be on a stable and well tolerated
dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the
treatment of IgAN. Subjects are expected to stay on the ACEi/ARB, SGLT2i and/or the
ERAs/MRAs for the duration of the study.

- Body mass index (BMI) between 18 and 40 kg/m^2.

- Screening weight of 45 to 150 kg.

- Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and
Coordination Group [CTFG] 2020) must agree to follow protocol-specified contraception
guidance from Screening through approximately 5 half-lives (24 weeks) after the final
dose of study drug. Use of hormonal contraceptive agents must have been initiated > 1
month prior to first dose of study drug.

- Provide written informed consent and be willing to comply with study visits and
procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Secondary forms of IgAN as determined by the Investigator, in the setting of systemic
disorders, infections, autoimmune disorders or neoplasias.

- Diagnosis of IgA Vasculitis.

- Current or history of nephrotic syndrome.

- Average blood pressure > 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at
the initial Screening visit. If blood pressure is too high, the 3 readings may be
repeated once within the Screening period if clinically appropriate as per the
Investigator.

- Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on
KDIGO guidelines

- Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from
any condition or another glomerulopathy/podocytopathy other than IgAN.

- History of Type 1 Diabetes.

- Subjects with Type 2 diabetes are excluded if any of the following are present:

- Screening HbA1c (glycated hemoglobin) of > 8%.

- Evidence of diabetic changes on kidney biopsy, performed for any reason.

- History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy)
and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular
disease, cerebrovascular disease).

- Unstable anti-diabetic regimen:

- Prior exposure to any antibody directed against APRIL.

- History of a previous severe allergic reaction with generalized urticaria, angioedema,
or anaphylaxis, including a history of allergy or hypersensitivity to any component of
BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.

- Received an investigational new drug within 28 days or 5 half-lives, whichever is
longer, prior to Screening.

- Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for >
14 days within 12 weeks prior to Screening.

- Use of systemic immunosuppressant medications.

- Any confirmed or suspected immunosuppressive or immune-deficient state, including but
not limited to common variable immunodeficiency (CVID), HIV infection or asplenia,
history of bone marrow or organ transplantation with exception of corneal transplants.

- Current severe infection requiring antimicrobials or history of recurrent, severe,
infections as determined by the Investigator.

- Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis
B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus
(HCV) antibodies (subjects who completed treatment and are persistently antibody be
allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.

- Received a live vaccination within 12 weeks prior to Screening or plan to have a live
vaccination within 6 months after the last dose of study drug.

- History of malignancy unless cancer free for at least 5 years or non-melanoma skin
cancer that was completely resected. A subject with curatively treated cervical
carcinoma in situ is eligible for the study. Subjects with low-risk prostate cancer
(i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are allowed.

- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the
study period and until 24 weeks after last dose.

- History or evidence of any other clinically significant disorder, condition, disease,
or laboratory finding that, in the Investigator's assessment, would place the subject
at unacceptable risk, limit compliance with study requirements, or confound
interpretation of study results.

- IgG levels < 6 g/L at Screening.

- Participation in another interventional trial with an investigational agent/device is
prohibited during the course of this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/05/2028
Actual
Sample size
Target
292
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Renal Research - Gosford
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Nepean Hospital - Penrith
Recruitment hospital [4] 0 0
Cairns Hospital - Cairns North
Recruitment hospital [5] 0 0
Box Hill Hospital-5 Arnold St - Box Hill
Recruitment hospital [6] 0 0
Sunshine Hospital - Australia - St Albans
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2750 - Penrith
Recruitment postcode(s) [4] 0 0
4870 - Cairns North
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autónoma De BuenosAires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autónoma de Buenos Aires
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul Teugbyeolsi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chinook Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Trial website
https://clinicaltrials.gov/ct2/show/NCT05852938
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05852938